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Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
---|---|---|---|---|---|---|---|---|---|---|---|
28/03/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 21117 | CODEINE SULFATE USP POWDER | 2007-11-30 | Active | II | Complete | 2014-08-04 | 2014-07-28 |
28/03/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
MALLINCKRODT INC | 5233 | CODEINE SULFATE | 1984-02-17 | Inactive | II | N/A |